Behavior Therapy vs Education for Persistent Headache After Mild TBI

VA Office of Research and Development

Status: Begins enrollment in a year or more

Conditions: Post-Traumatic Headache

Treatments: Behavioral: Headache education; Behavioral: Headache reprocessing

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07229391

1IK2RD001566-01A1 (Other Grant/Funding Number)

NURP-008-25S

Details and patient eligibility

About

This study will test a new treatment, called Headache reprocessing, for persistent post-traumatic headache. The new treatment will be compared to a headache education intervention. The main objectives of the study are to examine the feasibility, safety, and clinical appropriateness of the new treatment.

Full description

Persistent post-traumatic headache (PPTH) is a common, debilitating health condition affecting Veterans and civilians. Relative to other headache disorders, PPTH is especially severe and impairing. PPTH has no established first-line treatments at this time. This research seeks to develop a new behavioral treatment, called headache reprocessing, to target fear and avoidance behaviors and cognitions, and associated neural changes, that drive PPTH. This trial will test the feasibility, safety, and clinical appropriateness of Headache Reprocessing Therapy by comparing it to a headache education control condition in a randomized controlled trial. We will randomize 60 Veterans with PPTH to take part in this study. Headache reprocessing and the educational control intervention will be delivered in group format over eight sessions (one per week for eight weeks). This intervention has the potential to improve available treatment options for PPTH.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Enrolled in healthcare at VA San Diego Healthcare System;
2. History of mild TBI (mTBI), or head injury that is below the diagnostic threshold for mTBI
3. Headache that had its lifetime onset or significantly worsened within 90 days of a concussive event
4. Headache has persisted for at least 90 days since its onset or worsening
5. No changes in past 3 months to medical management of headache or comorbid psychiatric symptoms, and no anticipated changes during the study interval
6. No current participation in psychological intervention for pain or headache

Exclusion criteria

1. History of moderate or severe traumatic brain injury
2. Uncontrolled bipolar, psychotic, or substance use disorder
3. Acute suicidality as determined by screening as "high risk" or has a history of suicide attempt within the past 1 year;
4. Other factors that would preclude participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Headache reprocessing

Experimental group

Description:

Behavior therapy focused on sensations and avoidance behaviors

Treatment:

Behavioral: Headache reprocessing

Headache education

Active Comparator group

Description:

Education about ways to limit and manage headaches

Treatment:

Behavioral: Headache education